The NFU welcomes the opportunity to comment
on this topic and would respond as follows:

1. INTRODUCTION

The NFU, in concert with COPA/COGECA, welcomes
the introduction of emerging biotechnological innovation into
farming. It can provide clear advantages, although, as with any
other new technology, there are also recognised risks that have
to be addressed. As a recent COPA/COGECA document states, "authorization
of placing GMOs on the European Union market must be based on
comprehensive assessment of experimental data over a sufficiently
long period so as to provide the general public with maximum security
for human and animal health as well as environmental protection".
A copy of this document is appended (Appendix 1). It should also
be mentioned that this approach is similar to that of the European
Parliament Committee on Agriculture and Rural Development as stated
in the report on the impact of biotechnology on agriculture (Appendix
2) [not printed]. A similar approach has been developed
by the NFU as is outlined in the appended Report of the Biotechnology
Working Group, March 1998 (Appendix 3).

2. THEPRESENT
UK REGULATORYSYSTEM

The two regulatory bodies that are involved
in biotechnology topics as they relate to farming in the UK are
the Advisory Committee on Releases into the Environment (ACRE),
and the Advisory Committee on Novel Foods and Processes (ACNFP).
One of the possible difficulties with these two committees is
that they have different departmental loyalties. ACRE have the
responsibility of "advising the Secretary of State on human
health and environmental safety concerning the release of GMOs
into the environment". It is serviced by the Department of
the Environment, Transport and the Regions. The remit of the ACNFP
is to "advise Health and Agriculture Ministers of Great Britain
and the Heads of the Departments of Health and Agriculture Ministers
of Great Britain and the Heads of the Departments of Health and
Social Services and Agriculture for Northern Ireland on any matters
relating to the irradiation of food or to the manufacture of novel
foods or foods produced by novel processes having regard where
appropriate to the views of relevant expert bodies". It is
serviced by the Department of Health and the Ministry of Agriculture,
Fisheries and Food.

While we understand that there has been informal
contact between ACRE and the ACNFP we welcome the proposal in
the white paper on the Food Standards Agency that the responsibility
for both ACRE and the ACNFP are to be subsumed by this new agency
on its formation. This should lead to a more integrated approach
to the regulation of genetically modified organisms (GMOs) and
their use in agriculture and food.

The NFU also welcomes the acceptance of the
recommendation of the Lamming Committee for the creation of an
independent Advisory Committee on Animal Feedingstuffs. No doubt
this committee will have to take account of the need to properly
label animal feedstuffs that will increasingly contain genetically
modified constituents. The proposed changes to amend EC Directive
79/373 and repeal Directive 82/471, which relates to the specific
raw materials in animal feedstuffs, should be relevant to the
activities of this new committee. The new Directive contains sections
that are concerned with the requirements to ensure that animal
feedstuffs are appropriately labelled, including information on
constituents derived from GMOs.

An unexpected recommendation included in the
white paper was that animal biotechnology will continue to be
under the purview of the Department of Agriculture. While there
may turn out to be aspects of this subject that are not appropriately
covered by ACRE or the ACNFP, or their successors, there will
appear to be a need for consultative processes to be established
when the Food Standards Agency has been put in place.

4. A SUGGESTEDOVER-ARCHINGCOMMITTEE

One of the criticisms of the present UK regulatory
structure that always arises when non-governmental organisations,
the NFU and industry representatives come together to discuss
biotechnology is the lack of an over-arching body. Such a body
would be expected to discuss more global issues, such as is it
advisable for UK agriculture to go the route of using herbicide
tolerant or pesticide-containing genetically modified crops? The
inclusion of ACRE and the ACNFP in the Food Standards Agency would
present the ideal opportunity for such an over-arching committee
to be established.

5. PROPOSEDCHANGESTOTHEREGULATORYPROTOCOLS

In general the NFU considers that the present
UK system has worked well. However, there have been some difficulties
presented by the system and some additional procedures would be
sensible prior to commercial growing of GM crops in the UK.

(a) Post-release monitoring

The NFU is concerned that there is currently
no requirement for monitoring possible environmental changes after
consent to market has been granted. We recognise that widespread
monitoring could be difficult and costly and that a condition
of the consent to market a GMO requires the applicant to inform
the Secretary of State of any environmental problems that subsequently
occur. Nevertheless the NFU has proposed that a post-release monitoring
programme be instituted. The monitoring programme should be independent
of the company that is expected to profit from the GMO, should
be paid for by govnerment, and should be directed by govnerment,
or under govnerment contract. The post-release monitoring programme
should extend over a period of, say, 10 years and the review that
derives from it should form the basis for the continued licensing
of the GM crop. The report and data that arise from the monitoring
programme should be in the public domain. Any major environmental
changes that arise within the monitoring period could lead to
immediate withdrawal of approval. Prompt action would then have
to be taken to limit environmental damage if such an event occurred.

The NFU welcomes the suggested changes to EC
Directive 90/220 on deliberate release of genetically modified
organisms to the environment which include a provision for a mandatory
monitoring of products after they have been placed on the market
linked to a consent granted for a fixed time period of seven years.

(b) Antibiotic-resistant marker genes

One of the first genetically modified crops
that was adopted for commercial planting was Novartis's (formerly
Ciba-Giegy's) Bt maize. This contains an antibiotic-resistant
"marker" gene. The ACNFP recommended against the authorisation
of this product for growing in the UK and Europe because of the
perceived risk of the marker gene being transferred to the bacterial
inhabitatants of the gut of livestock fed with feedstuffs that
included it, and the eventual possibility of the antibiotic resistance
being passed on to human pathogens. This risk was considered to
be low but it was felt that further investigations were warranted
before the use of the maize was authorised. This recommendation
was eventually overturned by an EC majority vote, which led to
considerable public protest in various parts of the EU. The whole
matter is not yet resolved as various legal and technical challenges
to the decision have not yet been concluded. For example, Austria
is still refusing to accept the maize. It is ironic that the level
of risk is presently being investigated via several MAFF research
contracts. It would have been prudent for the EU to have insisted
on such investigations before growing authorisation was
granted. In the event the Bt GM maize is being commercially
grown in the EU for the first time this year. It is estimated
that between 1,000-2,000 hectares are being grown in France, and
some 15,000 hectares in northern Spain.

A precautionary principle should be the basis
for all EU decisions of this sort. If there is any doubt as to
the safety of a product it should not be authorised for
use in the EU unless the level of risk has been determined through
properly targeted scientific and technical research. The two terms
are used advisedly, as knowledge of the likelihood of gene transfer
between maize in feedstuff and gut bacteria requires scientific
investigation, but information is also needed as to whether the
DNA of concern is properly inactivated by the maize processing
regimes, which in essence is a technical problem.

(c) Test site information provision

The upsurge in eco-terrorist actions has brought
into sharp relief the difficulties posed by the UK regulatory
system that makes available full information of the location of
a GM crop test site before growing is undertaken. There is clearly
a "right to know" issue here as far as the general public
are concerned. However, giving potential eco-terrorists detailed
information that will allow them to unlawfully destroy test sites
hardly seems helpful and should be reviewed.

6. CODESOFPRACTICE

One way of assisting farmers and growers, and
other members of the agri-food chain, to deal with the introduction
of GM crops is to develop appropriate codes of practice for growing
them. Two have so far been produced and were introduced in April
1997. The first was the joint BSPB/NFU/UKASTA Code of Practice
on the provision of information relating to genetically modified
crops, and the second was the NFU Code of Practice to establish
a consistent approach to providing information to farmers and
growers regarding genetically modified crops. In addition there
was a joint response to the MAFF consultation on genetically modified
herbicide tolerant crops produced by the BAA, BSBSPA, BSPB, NFU
and UKASTA (these three documents are provided as Appendix 4).

One feature of the codes is the requirement
for a clear identifier that a seed is genetically modified to
be placed on all seed packets/sacks. This should be supplemented
by more detailed information, which should be supplied in a leaflet
that accompanies the seed, sales literature and the NIAB recommended
lists. The explanatory information should provide details of the
specific genetic modification, and should give details of the
agronomy of the GM plant. Farmer training schemes may also be
necessary. When the crop is harvested the produce should be identity
preserved so that the GM crop can be segregated from the non-GM
crop if it is deemed to be necessary. Each GM crop consignment
should be accompanied by a post-harvest declaration, which should
also include the name of the variety. The provision of such information
should be maintained during subsequent transportation. These codes
of practice will require detailed record keeping both on and off
farm, which form the basis of traceability of the crop.

As a result of these activities a group has
been formalised to extend such initiatives. It is the Supply Chain
Initiative for Modified Agricultural Crops (SCIMAC). At present
its members are in the process of completing a set of guidelines
for growing herbicide tolerant crops. The intent of all these
actions is to ensure that the commercial growing of GM crops in
to the UK is carried out in a responsible manner.

7. LABELLING

The situation with labelling brings into sharp
relief the chaos that has undermined the credibility of the EU
regulatory actions with regard to the introduction of GMOs. The
hard won EC Directive on Novel Foods and Novel Food Ingredients
(Regulation No. 258/97), which was intended to harmonise regulatory
controls in Europe, came into force in May 1997. It was expected
to calm consumers' concerns about GMOs. Unfortunately it did not
do so. The problem was that the regulation did not cover GM products
that had previously been approved or ones that were presently
being considered. Some consumers have also been concerned that
a food was only considered to be a "novel" one, and
so covered by the legislation, if it was "no longer equivalent"
to an existing one. In addition, while a particular food may not
be covered by the novel food regulations, there can be consumer
concerns about how a particular product had been produced (an
example of this could be sugar that had been produced from GM
herbicide tolerant sugar beet).

The problem was that genetically modified soya
and maize, grown in the USA or Canada (and now in other countries)
was being imported into the UK and Europe in increasing amounts.
It was not segregated so that the separation of GM soya or maize
from non-GM soya or maize was not possible. The products of either
crop were not considered to be covered by the novel food regulations
so that no special labelling was required. Extensive public unease
about this situation caused a re-think in this attitude. A decision
was made to produce an EC regulation that covered the labelling
of products that contained derivatives of GM soya and maize. This
is EC Regulation No. 1813/97 that directed that "genetically
modified soya beans covered by decision 96/281/E", and "genetically
modified maize covered by decision 97/98/E" should now be
covered by the Novel Food Regulation, and should consequently
be labelled. However, this regulation is still not in place, although
agreement on the components of it has now been reached. For example,
a third category of labelling of "may contain GM material"
has been removed. Also, labelling will only be required if a product
contains novel protein or DNA. A list of products that do not
need to be labelled is to be produced.

In the meantime, the Institute of Grocery Distribution,
of which the NFU is a member, instituted voluntary labelling guidelines
in November 1997 for products that contained soya. The basis of
these guidelines was that any food that contained soya
probably contained at least a very small amount of GM soya, so
that all such products should be labelled as "containing"
GM soya. This labelling initiative has also been supported by
the Business Retailing Consortium and the Food and Drink Federation.
The voluntary guidelines have now been extended to include foods
containing maize. Labelling of on-shelf foods under this scheme
started in early 1998 and should be completed by the end of the
year.

It is clear that, commendable as it might be,
the voluntary labelling scheme would never have been necessary
if the EU had dealt with the problem with speed and precision
at the outset. One of the major difficulties with the EC is that
it has to balance the conflicting requirements of its member countries.
This often means that decisions can be very slow in coming, and
that when they do occur the regulations are not always sufficiently
detailed to deal with the problem at hand.

8. EC DIRECTIVEFORTHELEGALPROTECTIONOFBIOTECHNOLOGICALINVENTIONS

Following many years of negotiations, and the
failure of the 1995 draft EC Directive because of ethical objections,
a revised version has recently been accepted by the European Parliament.
It should be noted that the NFU has been one of the groups instrumental
in ensuring that clauses were included in the revised version
of the Directive that should protect farmers' rights with regard
to GM crops and livestock. These rights would include the right
to "use the product of his harvest for the reproduction or
propagation by him on his own farm", and "implies authorization
for the farmer to use protected livestock for an agricultural
purpose. This includes the sale for the purpose of agricultural
activities". The NFU welcomes the new Directive as it is
felt that it will harmonise regulations in the EU and will produce
a legislative atmosphere that should encourage innovation in the
biotechnology area in Europe. However, it should be pointed out
the Directive is thought to be likely to come into force in September
2001, two years after completion of the necessary ratification
procedures in the member states. Such a lengthy delay points out
the limitations of the EU regulatory system in comparison with
those of a nation state such as the UK.

9. INTERNATIONALHARMONISATION

The NFU is concerned that products of genetic
modification are reaching the market in Europe before harmonised
controls are in place. We believe that international guidelines
for safety assessment are crucial and support programmes being
developed in this area by the United Nations Environmental Programme,
the World Health Organisation, the United Nations Food and Agriculture
Organisation, the Organisation for Economic Co-operation and Development,
and Codex Alimentarius.

The NFU is aware of the concerns of underdeveloped
and developing countries on the possible exploitation by multinational
companies of products derived from their naturally occurring flora
and fauna. The NFU supports attempts to develop international
agreements in this area.

10. INFORMATION

One of the failings of the UK and EU regulatory
climate is the lack of accurate information that has been provided
to the general public. Individual bodies such as the NFU, IGD,
FDF, and individual supermarkets have provided some information.
However, with some notable exceptions, such as the BBSRC, government
sources have not done so. It is the opinion of the NFU that a
government funded information strategy should be devised so that
the benefits and possible risks of the introduction of biotechnology
into farming could be presented in a balanced manner from a source
that is (hopefully) regarded as neutral. This would aid in countering
the distorted information on biotechnology that is often presented
by non-governmental organisations that are opposed to the technology.

Acronyms

ACNFPAdvisory Committee on Novel Foods and
Processes

ACREAdvisory Committee on Releases into the
Environment

BAABritish Agrochemicals Association

BSBSPABritish Sugar Beet Seed Producers Association

BBSRCBiotechnology and Biological Sciences
Research Council

BSPBBritish Society of Plant Breeders

BTBacillus thuringiensis
(a soil bacterium that is a natural source of pesticides)